Department of Health and Human Services May 2007 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 378
Center for Scientific Review, Amended Notice of Meeting
Document Number: 07-2424
Type: Notice
Date: 2007-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review, Amended Notice of Meeting
Document Number: 07-2423
Type: Notice
Date: 2007-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review, Amended Notice of Meeting
Document Number: 07-2422
Type: Notice
Date: 2007-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 07-2418
Type: Notice
Date: 2007-05-17
Agency: National Institutes of Health, Department of Health and Human Services, Department of Heatlh and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cosmetic Labeling Regulations
Document Number: E7-9436
Type: Notice
Date: 2007-05-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Cosmetic Labeling Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization
Document Number: E7-9435
Type: Notice
Date: 2007-05-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Statement of Organization, Functions and Delegation of Authority
Document Number: E7-9420
Type: Notice
Date: 2007-05-16
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Statement of Organization, Functions and Delegation of Authority
Document Number: E7-9419
Type: Notice
Date: 2007-05-16
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Determination That MEPRON (Atovaquone) Tablets, 250 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E7-9348
Type: Notice
Date: 2007-05-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that MEPRON (atovaquone) tablets, 250 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for atovaquone tablets, 250 mg.
Draft Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information; Availability
Document Number: E7-9347
Type: Notice
Date: 2007-05-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Labeling for Human Prescription DrugsDetermining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.'' This guidance is intended to help applicants and the review staff in the Center for Drug Evaluation and Research (CDER) at FDA determine when a drug belongs to an established pharmacologic class as well as how to select the appropriate word or phrase (term) that describes the pharmacologic class for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling.
Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability
Document Number: E7-9345
Type: Notice
Date: 2007-05-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.'' This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications. Applicants are encouraged to use this guidance to design cancer clinical trials and to discuss protocols with the agency. This guidance provides background information and discusses general regulatory principles. Additional companion guidances will follow and will focus on endpoints for specific cancer types (e.g., lung cancer, colon cancer) to support drug approval or labeling claims. This guidance, and the subsequent indication-specific guidances, should speed the development and improve the quality of protocols submitted to the agency to support anticancer effectiveness claims.
Tribal Management Grant Program
Document Number: 07-2389
Type: Notice
Date: 2007-05-16
Agency: Department of Health and Human Services, Indian Health Service
Meeting of the National Vaccine Advisory Committee
Document Number: E7-9346
Type: Notice
Date: 2007-05-15
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-9279
Type: Notice
Date: 2007-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-9276
Type: Notice
Date: 2007-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-9274
Type: Notice
Date: 2007-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-9272
Type: Notice
Date: 2007-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-9269
Type: Notice
Date: 2007-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 07-2369
Type: Notice
Date: 2007-05-15
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank
Document Number: E7-9221
Type: Notice
Date: 2007-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information contained in the guidance entitled ``Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions'' dated March 18, 2002.
Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
Document Number: E7-9220
Type: Notice
Date: 2007-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on recordkeeping requirements for applying hazard analysis and critical control point (HAACP) procedures for safe and sanitary processing for processors of fruit and vegetable juice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations
Document Number: E7-9219
Type: Notice
Date: 2007-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Toxicology Program (NTP); Liaison and Scientific Review Office; Meeting of the NTP Board of Scientific Counselors
Document Number: E7-9174
Type: Notice
Date: 2007-05-14
Agency: Department of Health and Human Services
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Submission for OMB Review; Comment Request; Evaluation of User Satisfaction With NIH Internet Sites
Document Number: E7-9173
Type: Notice
Date: 2007-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. The proposed information collection was previously published in the Federal Register on January 22, 2007, in Volume 72, No. 13, pg. 2700, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Evaluation of User Satisfaction with NIH Internet Sites. Type of Information Collection Request: New. Need and Use of Information Collection: Executive Order 12862 directs agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. With this submission, the NIH, Office of Communications and Public Liaison, seeks to obtain OMB's generic approval to conduct customer satisfaction surveys. Since the late 1980's, the NIH has seized the opportunity to disseminate information and materials via the Internet. Today, rapid technological changes of the WWW warrant on-going constituent and resource analysis. With survey information, the NIH is enabled to serve, and respond to, the ever-changing demand by the public. The `public' includes individuals (such as patients, educators, students, etc.) and interested communities (such as national or local organizations/institutions) and business. Survey information will augment current Web content, delivery, and design research that is used to understand the Web user, and more specifically, the NIH user community. Primary objectives are to (1) classify NIH Internet users; (2) summarize and better understand customer needs; and (3) quantify the effectiveness/efficiency of current tools and delivery. Overall, the Institutes, Centers, and Offices of the NIH will use the survey results to identify strengths and weaknesses in current Internet strategies. Findings will help to (1) understand user community and how to better serve Internet users; (2) discover areas requiring improvement in either content or delivery; (3) realize how to align Web offerings with identified user need(s); and (4) explore methods to offer and deliver information with efficacy and equity. Frequency of Response: On occasion [As needed on an on-going and potentially concurrent basis (by Institute, Center, or Office)]. Affected Public: Users of the Internet. Primarily, this is an individual at their place(s) of access including, but not limited to, home or/and work environments. Type of Respondents: Public users of the NIH Internet site, https://www.nih.gov, which may include organizations, medical researchers, physicians and other health care providers, librarians, students, as well as individuals of the general public. Estimated Number of Respondents: 104,000. Number of Respondents Per Respondent: 1. Average Burden Hours Per Response: 0.084. Burden Hours Requested: 8684. Total annualized cost to respondents is estimated at $130,260. There are also no capital costs, operating costs and/or maintenance costs to report.
Notice of Meeting
Document Number: 07-2365
Type: Notice
Date: 2007-05-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
National Institute of Mental Health, Notice of Closed Meeting
Document Number: 07-2348
Type: Notice
Date: 2007-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 07-2347
Type: Notice
Date: 2007-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 07-2346
Type: Notice
Date: 2007-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 07-2345
Type: Notice
Date: 2007-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 07-2344
Type: Notice
Date: 2007-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: E7-9087
Type: Notice
Date: 2007-05-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-9079
Type: Notice
Date: 2007-05-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-9068
Type: Notice
Date: 2007-05-11
Agency: Office of the Secretary, Department of Health and Human Services
Surplus Properties; Notice
Document Number: C7-2262
Type: Notice
Date: 2007-05-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Department of Defense, Department of the Army, Army Department
Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008
Document Number: C7-2167
Type: Proposed Rule
Date: 2007-05-11
Agency: Department of Health and Human Services, Centers for Medicare & Medicaid Services
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
Document Number: 07-2328
Type: Notice
Date: 2007-05-11
Agency: Department of Health and Human Services
This notice announces the 16th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup [formerly Biosurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate Updates, and Policy Changes; and Hospital Direct and Indirect Graduate Medical Education Policy Changes
Document Number: 07-2206
Type: Rule
Date: 2007-05-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The final payment amounts and factors used to determine the updated Federal rates that are described in this final rule were determined based on the LTCH PPS rate year July 1, 2007 through June 30, 2008. The annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and continue to be effective each October 1. The final outlier threshold for July 1, 2007, through June 30, 2008, is derived from the LTCH PPS rate year calculations. We are also finalizing policy changes which include revisions to the GME and IME policies. In addition, we are adding a technical amendment correcting the regulations text at Sec. 412.22.
Guidance for Industry on Computerized Systems Used in Clinical Investigations; Availability
Document Number: E7-9056
Type: Notice
Date: 2007-05-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Computerized Systems Used in Clinical Investigations,'' dated May 2007. This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. Because the source data in source documentation are necessary for the reconstruction and evaluation of the trial to determine the safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation, i.e., electronic records. This guidance supersedes the guidance entitled ``Computerized Systems Used in Clinical Trials,'' dated April 1999; finalizes the draft guidance of the same title dated September 2004; and supplements the guidance for industry entitled ``Part 11, Electronic Records; Electronic SignaturesScope and Application,'' dated August 2003, and FDA's international harmonization efforts when applying guidance to source data generated at clinical study sites.
Draft Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects-Supervisory Responsibilities of Investigators; Availability
Document Number: E7-9055
Type: Notice
Date: 2007-05-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Protecting the Rights, Safety, and Welfare of Study SubjectsSupervisory Responsibilities of Investigators.'' This draft guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The draft guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E7-9054
Type: Notice
Date: 2007-05-10
Agency: Food and Drug Administration, Department of Health and Human Services
Vaccines and Related Biological Products Advisory Committee; Amendment of Notice
Document Number: E7-9053
Type: Notice
Date: 2007-05-10
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E7-9012
Type: Notice
Date: 2007-05-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E7-9011
Type: Notice
Date: 2007-05-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-8994
Type: Notice
Date: 2007-05-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
Document Number: E7-8900
Type: Notice
Date: 2007-05-09
Agency: Department of Health and Human Services, National Institutes of Health
Proposals to conduct research involving the deliberate transfer of a tetracycline resistance trait to Chlamydia Trachomatis have been submitted to the NIH Office of Biotechnology Activities (OBA). The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Chlamydia infections in humans. Under the NIH Guidelines, these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approval by the NIH Director as Major Actions. These proposals will be discussed at the June 19-21, 2007 meeting of NIH Recombinant DNA Advisory Committee.
National Toxicology Program (NTP); Report on Carcinogens; Request for Nominations of Scientific Experts for Review of Candidate Substances for the 12th Report on Carcinogens
Document Number: E7-8899
Type: Notice
Date: 2007-05-09
Agency: Department of Health and Human Services
On April 16, 2007, NTP released the final review process for preparation of the 12th Report on Carcinogens (RoC, 72FR18999, available at https://ntp.niehs.nih.gov/go/9732). This notice invites the public to nominate scientists to serve on expert panels. These scientists should have expertise and/or knowledge relevant to evaluation of the potential carcinogenic hazard of the candidate substances that will undergo review for the 12th RoC.
National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Request for Data on the Use of Topical Anesthetics and Systemic Analgesics for In Vivo Eye Irritation Testing
Document Number: E7-8898
Type: Notice
Date: 2007-05-09
Agency: Department of Health and Human Services
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM request the submission of data and information on the use of topical anesthetics and systemic analgesics for alleviating pain and distress in rabbits during eye irritation testing. They also request the submission of information about other procedures and strategies that may reduce or eliminate pain and distress associated with in vivo eye irritation methods.
National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review Panel Report on Five In Vitro Pyrogen Test Methods: Availability and Request for Public Comments
Document Number: E7-8896
Type: Notice
Date: 2007-05-09
Agency: Department of Health and Human Services
NICEATM in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) convened an independent scientific peer review panel meeting on February 6, 2007, to evaluate the validation status of five in vitro pyrogen test methods proposed as replacements for the Rabbit Pyrogen Test (RPT). The peer review panel (``the Panel'') report from this meeting is now available. The report contains (1) the Panel's evaluation of the validation status of the methods and (2) the Panel's comments and conclusions on draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel's report. The report is available on the NICEATM/ICCVAM Web site at (https://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm) or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below).
Government-Owned Inventions; Availability for Licensing
Document Number: E7-8895
Type: Notice
Date: 2007-05-09
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: E7-8894
Type: Notice
Date: 2007-05-09
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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